On June 10, 2019 Sesen Bio (Nasdaq:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for patients with cancer, reported that it has completed a successful Type B Pre-Biologics License Application (BLA) meeting regarding the approval path for Vicinium for the treatment of patients with high-risk,Bacillus Calmette-Guérin(BCG) unresponsive, non-muscle invasive bladder cancer (NMIBC) (Press release, Xoma, JUN 10, 2019, View Source [SID1234539296]). The Company has reached alignment with the U.S. Food and Drug Administration (FDA) on an Accelerated Approval Pathway for Vicinium along with Rolling Review, and the Company expects to initiate submission of the BLA in the fourth quarter of 2019. The FDA also indicated that the nonclinical data, the clinical pharmacology data, and the safety database are sufficient to support a BLA submission, and that no additional clinical trials are necessary for a BLA submission.

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Rolling Review of the BLA enables individual modules to be submitted and reviewed on an ongoing basis, rather than waiting for all sections to be completed before submission. The final module submission for the BLA will be CMC, and Sesen Bio plans to meet with the FDA in the second half of 2019 to discuss the content and timing of that module.

"We have now had two successful meetings with the FDA over the last three weeks, which build on our long-term relationship with the Agency and make our regulatory path forward for Vicinium even more clear," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Gaining alignment with the FDA on an Accelerated Approval Pathway, in addition to a rolling review of the BLA, significantly increases our confidence in our regulatory pathway and our ability to bring a product to market that has the potential to save and improve the lives of patients."

On May 21, 2019Sesen Bio announced a positive outcome from its previous meeting with the FDA, a Type C CMC meeting, where Sesen Bio reached agreement with the FDA on the Analytical Comparability Plan, and confirmed, subject to final comparability data to be provided in the BLA submission, that no additional clinical trials were deemed necessary for comparability.

Sesen Bio plans to schedule two additional meetings with the FDA in the second half of 2019, a Type C meeting to discuss the details of a post-marketing confirmatory trial in support of the Accelerated Approval Pathway for Vicinium, and a Type B CMC meeting to discuss the submission strategy of the CMC module.

Conference Call Information

To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 2958515. The webcast can be accessed in the Investor Relations section of the company’s website at www.sesenbio.com. The replay of the webcast will be available in the investor section of the company’s website at www.sesenbio.com for 60 days following the call.

About Vicinium

Vicinium, a locally-administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicinium is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of Bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On June 10, 2019 FibroGen, Inc. (NASDAQ: FGEN), a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics, reported that Chief Executive Officer Thomas B. Neff will participate in a Fireside Chat at the Goldman Sachs 40th Annual Global Healthcare Conference in Rancho Palos Verdes, California, on Wednesday, June 12, at 10:00 a.m. Pacific Time (Press release, FibroGen, JUN 10, 2019, View Source;p=irol-newsArticle&ID=2401014 [SID1234536975]). A live audio webcast of the presentation will be available under the Investors section of the FibroGen website at www.fibrogen.com. The replay of the webcast will be available for at least 14 days following the webcast.

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On June 10, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported U.S. Food and Drug Administration (FDA) approval of Polivy (polatuzumab vedotin-piiq), which is an antibody-drug conjugate (ADC) targeting CD79b that utilizes Seattle Genetics’ technology. Polivy was developed and will be commercialized by Genentech, a member of the Roche Group (Press release, Seattle Genetics, JUN 10, 2019, View Source [SID1234536977]). It was approved in combination with bendamustine plus Rituxan (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies. Polivy previously received FDA Breakthrough Therapy Designation, and was approved more than two months ahead of the Prescription Drug User Fee Act (PDUFA) action date of August 19, 2019.

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"The approval of Polivy under our collaboration with Genentech is an important milestone for Seattle Genetics as it extends the reach of our technology to more patients with significant unmet medical needs," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "This approval, along with our own internal ADCs in development and those of other collaborators, such as GlaxoSmithKline, highlights that ADCs continue to grow as an important therapeutic approach to treating both hematologic malignancies and solid tumors."

Polivy was granted PRIME (PRIority MEdicines) designation by the European Medicines Agency (EMA) for the treatment of patients with R/R DLBCL. PRIME is a designation implemented by the EMA to support data generation and development plans for promising medicines, providing a pathway for accelerated evaluation by the agency. Polivy is also being investigated by Genentech in several ongoing clinical trials for the treatment of non-Hodgkin lymphoma (NHL), including frontline DLBCL.

Seattle Genetics’ ADC technology combines the specificity of monoclonal antibodies, innovative linker systems and potent cell-killing agents to treat cancer. The technology has been licensed to several companies, including Genentech and GlaxoSmithKline. Under the terms of these agreements, each company has rights to use the technology with antibodies against selected targets. The licensee is responsible for research, product development, manufacturing and commercialization. Seattle Genetics is entitled to receive fees, progress-dependent milestone payments and royalties on worldwide net sales of any resulting ADC products.

On June 10, 2019 GT Biopharma, Inc. (OTCQB: GTBP) (OTCQB: GTBP.PA) an immuno-oncology company focused on innovative treatments based on the Company’s proprietary NK cell engager (TriKE) platform and Multi-Target Directed Bispecific Drug Conjugate (MTBDC) platform, reported an update of the company’s drug development programs (Press release, GT Biopharma , JUN 10, 2019, View Source [SID1234539512]).

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GT Biopharma continues to move forward with its development of the HIV TriKE. On April 24th GT Biopharma announced the elimination of HIV infected cells using its Tri:Specific Killer Engagers (TriKEs) in Preclinical Testing at the University of Minnesota. Which could represent a possible cure to HIV which now has over 35 million infected people worldwide.

About the HIV TriKE

In preclinical testing led by Dr. Jeffrey Miller, M.D., Deputy Director Masonic Cancer Center and Dr. Timothy Schacker, M.D., Medical School and Director, Program in HIV Medicine, the research team designed a series of Bispecific and Trispecific Natural Killer Cell Engagers (BiKE and TriKE) constructs to direct Natural Killer cell mediated cytotoxicity against an HIV infected target. The data demonstrate that a BiKE construct can eliminate HIV infected targets expressing the HIV envelope on their surface. Based on the success of the BiKE data, GT Biopharma is planning to develop a TriKE version by incorporating IL-15 into the BiKE scFv construct to increase the level of NK cell killing of targeted HIV infected cells.

Additional TriKEs (Trispecific NK cell engagers) which target hematological malignancies (liquid tumors), and solid tumor cancers, are also progressing under the TriKE platform. The TriKE platform’s ability to expand into solid tumors (80% of the cancer market) allows for a much more economical and wider approach then CAR-T. Most recently KITE Pharma was bought by Gilead Sciences, Inc. for $12 Billion (NASDAQ: GILD) and Juno Therpeautics was accuried ($9 Billion) by Celegene Corporation (NASDAQ: CELG). These highly expensive cell therapies are limited to only liquid tumors (20% of the cancer market). The TriKE off the shelf technology is a protein (drug) version of CAR-T using the TriKE’s ability to employ NK (Natural Killer) cells from the immune system as the catalyst to target, attack and kill specific cancers.

GTB-3550 (OXS-3550) is the Company’s first Tri-specific NK cell Engager (TriKE) product candidate being initially developed for the treatment AML. GTB-3550 (OXS-3550) is being readied to begin enrolling patients with advanced Acute Myeloid Leukemia (AML) in a Phase I/II expansion clinical trial starting mid- July 2019.

About GTB-3550 Trispecific NK cell Engager (TriKE)

GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. The natural killer (NK) cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill. We intend to study GTB-3550 in CD33 positive leukemias such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies.

GTB-1550 (DT2219) top-line Phase I/II expansion clinical trial results have been promising; two patients exhibited a complete remission (CR) with one patient currently disease-free at 50 months post completion of the study. A Phase 2 study is being planned.

About GTB-1550 Multi-Target Directed Bispecific Drug Conjugate

GTB-1550 targets cancer cells expressing the CD19 receptor or CD22 receptor or both receptors thereby maximizing cancer cell recognition by binding to CD19+, CD22+ and CD19+/CD22+ cancer cells. When GTB-1550 binds to cancer cells, the cancer cells internalize GTB-1550, and are killed due to the action of drug’s cytotoxic diphtheria toxin payload.

Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma, commented, "­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­We are pleased with the progress of our clinical development programs." The HIV TriKE’s possibility to kill the HIV virus would solve a massive economic burden as well as stop infected patients from spreading the disease. Mr. Cataldo also noted that the Company has two key platform technologies to attack cancer: the TriKE platform, and the Multi-Targeted Directed Bispecific Cytotoxic Payload platform. Mr. Cataldo stated, "We believe that these Platform technologies present first-in-class therapeutic opportunities for the Company, and will be the main focus going forward."

On June 10, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson have reported the latest research to be presented at the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress taking place in Amsterdam, The Netherlands, from 13–16 June 2019 (Press release, Johnson & Johnson, JUN 10, 2019, View Source [SID1234536978]). Janssen will present 28 company-sponsored abstracts from its leading haematological malignancy portfolio at the congress, including the latest results for DARZALEX (daratumumab) and IMBRUVICA (ibrutinib).

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"With more than 11,000 attendees, EHA (Free EHA Whitepaper) is the premier congress for the latest innovations in haematology in Europe and Janssen is proud to be presenting important data from our clinical development programmes," said Dr Patrick Laroche, Europe, Middle East and Africa (EMEA) Haematology Therapeutic Area Lead, Janssen-Cilag France. "We are committed to changing outcomes and improving options for patients diagnosed with cancer. Therefore, we are pleased to present results from the daratumumab CASSIOPEIA study, which has been selected for inclusion in the Presidential Symposium. We are also encouraged by the five-year ibrutinib RESONATETM-2 follow-up findings, which provide longer-term evidence supporting the efficacy and safety of this BTK inhibitor in the treatment of chronic lymphocytic leukaemia."

Highlights of the data to be presented by Janssen include:

First-Time Daratumumab Data in the Treatment of Newly Diagnosed Patients with Relapsed/Refractory Multiple Myeloma, and its Investigational Subcutaneous Formulation1,2
Fourteen daratumumab abstracts have been selected for presentation at the EHA (Free EHA Whitepaper) Annual Congress this year, four of which will be featured in oral sessions. Notably, results from the Phase 3 CASSIOPEIA study evaluating daratumumab in combination with bortezomib, thalidomide and dexamethasone for newly diagnosed patients with multiple myeloma who are transplant eligible have been selected for presentation as part of the Presidential Symposium (Abstract #S145).1 The Presidential Symposium includes the six best abstracts of the Congress, reflecting ground-breaking research as chosen by the Scientific Program Committee. These data recently supported regulatory filings in both the European Union and the U.S., seeking to expand the current indication for daratumumab in the frontline setting.

Findings from the Phase 3 COLUMBA study will be presented (Abstract #S823) evaluating a daratumumab subcutaneous formulation in the treatment of patients with relapsed or refractory multiple myeloma.2

Ibrutinib Long-Term Data in Chronic Lymphocytic Leukaemia3
Results from the final analysis of the Phase 3 RESONATETM-2 study (PCYC-1115/1116) study evaluating ibrutinib monotherapy in previously untreated patients with chronic lymphocytic leukaemia (CLL) will be presented in an oral session (Abstract #S107).3 Ibrutinib, a once daily oral BTK inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.3

Select company-sponsored abstracts follow below. Abstracts for additional Janssen therapies will also be presented and can be found through the EHA (Free EHA Whitepaper) abstract database here.

Abstract No. Title Date/Time
Daratumumab
Oral Presentations
Abstract #S1451

Phase 3 Randomized Study of Daratumumab + Bortezomib/Thalidomide/Dexamethasone (D-VTd) Versus VTd in Transplant-eligible Newly Diagnosed Multiple Myeloma: Part 1 CASSIOPEIA Results Presidential Symposium,
Friday, June 14 3:45 – 4:00 PM CEST

Abstract #S8744

Efficacy of Daratumumab, Bortezomib, Thalidomide, and Dexamethasone in Transplant-eligible Newly Diagnosed Multiple Myeloma Based Minimal Residual Disease Status: Analysis of CASSIOPEIA Saturday, June 15
4:45 – 5:00 PM CEST

Abstract #S8232

Randomized, Open-label, Non-inferiority, Phase 3 Study of Subcutaneous Versus Intravenous Daratumumab Administration in Patients with Relapsed or Refractory Multiple Myeloma: COLUMBA Saturday, June 15
11:30 – 11:45 AM CEST

Abstract #S8755

Subcutaneous Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone in Patients with Newly Diagnosed Amyloid Light Chain Amyloidosis: Updated Safety Run-in Results of ANDROMEDA Saturday, June 15
5:00 – 5:15 PM CEST

Poster Presentations
Abstract #PF5986

Stem Cell Yield and Transplantation in Transplant-eligible Newly Diagnosed Multiple Myeloma Patients Receiving Daratumumab, Bortezomib, Thalidomide, and Dexamethasone: Phase 3 CASSIOPEIA Study Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF5927

Impact of Age on Efficacy and Safety of Daratumumab in Combination with Lenalidomide and Dexamethasone in Patients with Transplant-ineligible Newly Diagnosed Multiple Myeloma: MAIA Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF6038

Faster and Sustained Improvement in Health-related Quality of Life in Transplant-ineligible Newly Diagnosed Multiple Myeloma Patients Treated with Daratumumab, Lenalidomide, and Dexamethasone (D-Rd) Versus Rd: MAIA Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF5919

Efficacy and Safety of Daratumumab, Lenalidomide, and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Updated Subgroup Analysis of POLLUX Based on Cytogenetic Risk Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF59610

Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Updated Subgroup Analysis of CASTOR Based on Cytogenetic Risk Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF64111

Characterization of Treatments and Real-life Outcomes in Patients with Newly Diagnosed Multiple Myeloma Who Received Frontline Autologous Stem Cell Transplantation in Sweden Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF64312

Characterization of Frontline Treatment Patterns and the Proportion of Patients Reaching Subsequent Lines of Therapy in Transplant-eligible Patients with Newly Diagnosed Multiple Myeloma Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PS137713

Improvement in Health-related Quality of Life for Newly Diagnosed Multiple Myeloma Transplant-eligible Patients Treated with Daratumumab, Bortezomib, Thalidomide, and Dexamethasone: CASSIOPEIA Saturday, June 15
5:30 – 7:00 PM CEST

Abstract #PS142514

Results of the Daratumumab Monotherapy Early Access Treatment Protocol in Patients from Europe and Russia with Relapsed or Refractory Multiple Myeloma Saturday, June 15
5:30 – 7:00 PM CEST

Abstract #PS139515

Comparative Effectiveness of Frontline Treatments for Patients with Newly Diagnosed Multiple Myeloma Who are Transplant-ineligible Saturday, June 15
5:30 – 7:00 PM CEST

Ibrutinib
Oral Presentation
Abstract #S1073

Five Year Follow-Up of Patients Receiving Ibrutinib For First-Line Treatment of Chronic Lymphocytic Leukemia Friday, June 14
12:00 – 12:15 PM CEST

Poster Presentations
Abstract #PF38416

Effectiveness and Safety of Ibrutinib for Chronic Lymphocytic Leukemia (CLL) in Routine Clinical Practice: Interim Analysis (IA) of the Belgian Ibrutinib Real-World Data (BIRD) Study Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF38717

French Ibrutinib Observational Study (FIRE): Real-World Study of Ibrutinib Treatment for Chronic Lymphocytic Leukemia (CLL) in France Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF38318

Prognostic Testing and Treatment Approaches Based on Real-World Clinical Experience from An Interim Analysis of the INFORMCLL Registry of Patients With Chronic Lymphocytic Leukemia [ASH encore] Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF49419

Clinical Outcomes with Single-Agent Ibrutinib for Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL): Interim Analysis (IA) of the Belgian Ibrutinib Real-World Data (BIRD) Study Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PF38920

Progression-Free Survival Predicts Overall Survival in Frontline CLL Friday, June 14
5:30 – 7:00 PM CEST

Abstract #PS126421

French Ibrutinib Observational Study (FIRE): Real-World Study of Ibrutinib Treatment for Mantle Cell Lymphoma (MCL) in France Saturday, June 15
5:30 – 7:00 PM CEST

#ENDS#

About daratumumab
Daratumumab is a first-in-class22 biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.23 Daratumumab is believed to induce tumour cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.24 A subset of myeloid-derived suppressor cells (CD38+ MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were decreased by daratumumab.26 Daratumumab is being evaluated in a comprehensive clinical development programme across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings.25,26,27,28,29,30,31,32 Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant haematologic diseases in which CD38 is expressed, such as smouldering myeloma.33,34 For more information, please see www.clinicaltrials.gov.

For further information on daratumumab, please see the Summary of Product Characteristics at View Source

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive licence to develop, manufacture and commercialise daratumumab.35

About ibrutinib
Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.36 By blocking this BTK protein, ibrutinib decreases survival and migration of B lymphocytes, thereby delaying the progression of the cancer.37

Ibrutinib is currently approved in Europe for:38

Chronic lymphocytic leukaemia (CLL): As a single agent for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy.
Mantle cell lymphoma (MCL): Adult patients with relapsed or refractory mantle cell lymphoma.
Waldenström’s macroglobulinemia (WM): Adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemoimmunotherapy.
Ibrutinib is approved in more than 90 countries, and, to date, has been used to treat more than 140,000 patients worldwide across its approved indications.

The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g. bruising), musculoskeletal pain, nausea, rash, and pyrexia.38

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.